Memantine Hydrochloride

Product NDC
55154-4151
11-digit product format
551544151
Labeler code
55154
Product ID
55154-4151_2104a25e-845b-4bea-8a82-5274b878961f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA090048
Marketing category
ANDA
Marketing start
2015-07-20
Substance
MEMANTINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Memantine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJY0WD0UA60
Rxcui996561, 996571

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
941773f8-a40e-0684-da08-ff9a143e6368Product name720231219
5b597f00-4538-4686-aa4e-3c60ed3788c8Product name220210511
1836e79a-a4d1-4087-2f2e-f878e8a1fef2Product name920151209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-4151-0Memantine Hydrochloride10 in 1 BAGTABLET, FILM COATED109
55154-4151-0Memantine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4151MEMANTINE TABLET [CARDINAL HEALTH 107, LLC]7Current NDC, Legacy NDC, 2 package rows20240724_65c9e7bc-71f0-4113-8de1-4fcaa591735f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN65c9e7bc-71f0-4113-8de1-4fcaa591735f9
996571memantine HCl 5 MG Oral TabletPSN65c9e7bc-71f0-4113-8de1-4fcaa591735f9
996561memantine hydrochloride 10 MG Oral TabletSCD65c9e7bc-71f0-4113-8de1-4fcaa591735f9
996571memantine hydrochloride 5 MG Oral TabletSCD65c9e7bc-71f0-4113-8de1-4fcaa591735f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4151-05515441510010 BLISTER PACK in 1 BAG (55154-4151-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2022-05-120000-00-00NoNoCurrent